510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Z-2193-2024Class II

COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator

Medtronic, Inc. / initiated 2024-04-16 / Open, Classified / root cause: manufacturing process
FDA source (opens on fda.gov)

Medtronic Inc. began a recall of COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator on . FDA classified it as Class II and gives the reason as "Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2193-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
Medtronic, Inc.
Product
COBALT XT HF QUAD CRT-D MRI SureScan, Model Number DTPA2Q1, Implantable Cardioverter Defibrillator
Product code
NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)
Reason for recall
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
On about 04/18/2024, Medtronic notified customers that they were retrieving distributed units that may have undergone a specific manufacturing sequence that requires additional engineering evaluation. They requested that customers acknowledge the letter with signature.
Quantity in commerce
11 units
Distribution
Worldwide - US Nationwide distribution in the states of CA, CT, FL, IN, MA, MI, NC, NH, NJ, NM, NY, OH, TX, VA and the countries of Australia, Austria, Bulgaria, Canada, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Guadeloupe, Iceland, Ireland, Italy, Jordan, Kosovo, Latvia, Moldova, Republic Of, Netherlands, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom.
Product codes and lots
GTIN: 00763000178109, Serial Numbers: RTD607545S, RTD607549S, RTD607551S; GTIN 00763000711177, Serial Numbers: RTD607363S, RTD607364S, RTD607367S, RTD607369S, RTD607370S, RTD607374S, RTD607404S, RTD607405S.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2193-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2190-2024Class IIOngoingVoluntary: Firm initiated
Z-2191-2024Class IIOngoingVoluntary: Firm initiated
Z-2192-2024Class IIOngoingVoluntary: Firm initiated
Z-2193-2024Class IIOngoingVoluntary: Firm initiated
Z-2194-2024Class IIOngoingVoluntary: Firm initiated
Z-2195-2024Class IIOngoingVoluntary: Firm initiated
Z-2196-2024Class IIOngoingVoluntary: Firm initiated
Z-2197-2024Class IIOngoingVoluntary: Firm initiated
Z-2198-2024Class IIOngoingVoluntary: Firm initiated
Z-2199-2024Class IIOngoingVoluntary: Firm initiated
Z-2200-2024Class IIOngoingVoluntary: Firm initiated
Z-2201-2024Class IIOngoingVoluntary: Firm initiated
Z-2202-2024Class IIOngoingVoluntary: Firm initiated
Z-2203-2024Class IIOngoingVoluntary: Firm initiated
Z-2204-2024Class IIOngoingVoluntary: Firm initiated
Z-2205-2024Class IIOngoingVoluntary: Firm initiated
Z-2206-2024Class IIOngoingVoluntary: Firm initiated
Z-2207-2024Class IIOngoingVoluntary: Firm initiated
Z-2208-2024Class IIOngoingVoluntary: Firm initiated
Z-2209-2024Class IIOngoingVoluntary: Firm initiated
Z-2210-2024Class IIOngoingVoluntary: Firm initiated
Z-2211-2024Class IIOngoingVoluntary: Firm initiated
Z-2212-2024Class IIOngoingVoluntary: Firm initiated